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Castleman's Disease – NCI-04-C-0275

Dr. Robert Yarchoan
Principal Investigator

NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with Castleman's disease. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Yarchoan and his staff directly.

You may also call the Clinical Studies Support Center at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.

Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity
NCI-04-C-0275

Patients are assigned to one of six treatment groups based on disease status.

Group I (observation only)

  • Patients with asymptomatic disease undergo observation only, or observation in conjunction with highly active antiretroviral therapy (HAART), where appropriate

Group II (high-dose zidovudine [HDAZT] and valganciclovir [VGCV])

  • Patients with symptomatic disease that is not life-threatening receive oral HDAZT four times daily and oral VGCV twice daily on Days 1–21; courses repeat every 21 days

Group III (bortezomib, HDAZT, and VGCV)

  • Patients with continued symptomatic disease who are not responding to group II therapy receive bortezomib IV over 3–5 seconds on Days 1, 4, 8, and 11 and HDAZT and VGCV as in group II on Days 1–21
  • Courses repeat every 21 days

Group IV (EPOCH-R)

  • Patients with life-threatening disease will receive EPOCH-R therapy comprising a 5-day course of rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone
  • Treatment repeats every 21 days for up to 6 courses

Group V

  • Patients may also receive rituximab IV and doxorubicin hydrochloride liposome IV for 3 to 6 courses followed by interferon alpha maintenance for 6 to 12 months

Group VI

  • Patients may also receive oral sirolimus daily with cycle length every 21 days

Why is this trial important?

This trial is important because KSHV-associated multicentric Castleman's disease is a poorly understood condition, and there is no standard medical treatment for the disease. This trial is designed to gather information about the disease and to develop new treatment strategies for the disease. The interventions being studied in this trial may have application to other rare diseases if they appear to be effective in this trial.

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